WO2010149906A1

WO2010149906A1 - Aerosol metering valve and device for dispensing a fluid material comprising such a valve

Info

Publication number: WO2010149906A1
Application number: PCT/FR2010/051228
Authority: WO
Inventors: Stéphane BUREL; Frédéric PIROU; Matthieu Savalle
Original assignee: Valois Sas
Priority date: 2009-06-22
Filing date: 2010-06-18
Publication date: 2010-12-29
Also published as: FR2946963B1; US8602272B2; FR2946963A1; EP2445811A1; US20120160878A1

Abstract

The invention relates to an aerosol metering valve (20), comprising a valve body (21) containing a metering chamber (25) defined between an upper seal (251) and a lower seal (252), a valve (30) sealingly sliding against said upper and lower seals (251, 252) in said metering chamber (25), said metering chamber (25) comprising at least one mobile element (100) that is freely movable in said metering chamber (25), said at least one mobile element having a substantially spherical shape, such as a ball.

Description

Aerosol metering valve and fluid dispensing device comprising such a valve

The present invention relates to an aerosol metering valve, and a fluid dispensing device comprising such a valve.

It is known to use aerosol dispensing valves, especially metering valves, for dispensing successive doses of medicaments, generally in the form of micronized powders containing the active ingredients mixed with propellants, generally of the HFA type, for example HFA- 134a and / or HFA-227. These metering valves are generally used in the inverted position, with the reservoir above the valve in use, and comprise a metering chamber which fills by gravity. When the storage time is long enough between two actuations, the dosing accuracy can be altered, in particular because of sticking phenomena of the principle (s) active (s) on the walls of the dosing chamber and / or sedimentation or creaming of the active principle (s). This results in a loss of homogeneity in the dispensed dose, and a poor reproducibility of dosing between several successive actuations. However, according to the dispensed drugs, it is generally desirable to optimize both the reproducibility of dosage (same dose of active ingredients distributed at each actuation) and the homogeneity of the dose (good distribution of active ingredients in the dispensed dose) to promote maximum effectiveness of the drug in the user. To overcome this problem, it has been proposed to have in the dosing chamber a mobile ring around the valve to homogenize the dose by shaking the device. US-5,593,069, JP 2000 197837 and JP 2001 114630 describe devices of this type. These rings, however, have disadvantages. They have an inertia that makes their travel difficult, especially for children or the elderly. In addition, they can retain product because of their large external surface, and thus limit the beneficial effect on dose reproducibility. The present invention aims to provide an aerosol dispensing valve that does not reproduce the aforementioned drawbacks.

More particularly, the present invention aims to provide an aerosol dispensing valve which reduces the Loss of Dose phenomenon between two successive actuations, even after a long storage time.

The present invention also aims to provide such a valve that optimizes the dispensing performance of the valve, in particular by optimizing the amount of active ingredients distributed at each actuation.

The present invention also aims to provide such a valve that is simple and inexpensive to manufacture and assemble.

The subject of the present invention is therefore an aerosol metering valve for dispensing fluid product, comprising a valve body containing a metering chamber defined between a high seal and a low seal, a valve sliding in a sealed manner against said up and down seals in said metering chamber, said metering chamber comprising at least one movable element freely displaceable in said metering chamber, said at least one movable element being of spherical shape, such as a ball. Advantageously, said at least one mobile element is of high density relative to the density of the fluid product contained in said metering chamber, and of small dimensions relative to the dimensions of said metering chamber.

Advantageously, said metering chamber comprises a plurality of movable elements, in particular two or three.

Advantageously, the reproducibility of the dose between two successive actuations, namely the quantity of active ingredients distributed during the second actuation with respect to the quantity of active ingredients distributed during the first actuation, is greater than 80%, advantageously greater than 85%, preferably greater than or equal to

90%. In a variant, said metering chamber comprises axial channels each containing at least one mobile element, in particular in the form of a ball.

The present invention also relates to a fluid dispenser device comprising a reservoir, and having a valve as described above.

Advantageously, said valve is assembled on said reservoir by means of a fixing element, such as a crimping capsule.

Advantageously, a ring is assembled around said valve body, said ring having a rigid inner portion cooperating with the valve body and a radially deformable outer portion.

Advantageously, said fluid product comprises active ingredient (s) in the form of a micronized powder mixed with propellant gas, in particular of the HFA-134a and / or HFA-227 type, in the possible presence of one or more excipients. (s).

These and other features and advantages of the present invention will appear more clearly in the following detailed description given with reference to the accompanying drawings, given by way of non-limiting example, and in which FIG. 1 is a diagrammatic view in section. cross section of an aerosol dispensing device according to an advantageous embodiment of the present invention, in the upright position.

With reference to this FIG. 1, the aerosol device comprises a reservoir 1 containing the fluid product to be dispensed, of which only a portion of the neck has been shown in dashed lines in FIG. 1. This fluid product may be of the pharmaceutical type, and of the propellant gas. , in particular of the HFA type, may be provided for dispensing this product through an aerosol valve 20, preferably a metering valve. One or more excipients may also be added to the mixture, if necessary.

This aerosol valve comprises a valve body 21 in which slides a valve 30, preferably formed of a valve top 31 incorporating the outlet orifice 35 of the valve, and a lower valve 32 cooperating with a spring 70 which urges the valve 30 towards its position of rest shown in Figure 1. Advantageously, said upper valve 31 is fitted on said lower valve 32.

The valve body 21 is assembled on the neck of the tank 1 by means of a ring or attachment cap 50, in particular of the crimpable type, preferably with the interposition of a neck seal 40 to seal.

The valve shown is particularly intended to be used in the inverted position, that is to say that when a dose is expelled, the valve is located below the tank. This valve may however also be suitable for valves used in the upright position. In this case, the valve body may be equipped with a tube for delivering the liquid into the chamber via the valve body.

The valve body 21 has one or more openings 22 for filling the valve with product from the reservoir. These openings are shown in the form of lateral longitudinal slots 22 extending over a portion of the height of the valve body 21. Alternatively, one or more openings (s) of different shapes could be provided for this purpose.

The valve body 21 contains a metering chamber 25, typically defined between a top seal 251 and a bottom seal 252 against which the valve 30 slides sealingly. The dosing chamber

25 may further be defined by a hollow insert 255 disposed in the valve body 21 between said top 251 and bottom 252 seals as shown in FIG.

A ring 10 can be assembled around the valve body 21. This ring 10 is intended primarily to perform two functions, namely on the one hand ensure the most complete possible draining of the tank, limiting as much as possible the dead volume located below the lower edge of the opening (s) 22 of the valve body 21, when the valve is in the reverse use position. On the other hand, the ring also serves to limit as much as possible the contact between the product contained in the reservoir 1 and the neck seal 40. Advantageously, the ring can prevent any contact between the product and the neck seal 40, by forming a seal with part of the reservoir after crimping the capsule 50. The ring 10 may comprise at least one inner portion 11 which is intended to cooperate with the valve body 21, and an outer portion 15, preferably radially outermost, which may comprise a portion of deformable axial wall capable of deforming elastically radially inwards. This deformable wall is intended in particular to compensate for and absorb any radial stresses that may be exerted on it by the reservoir 1, particularly when at the time of crimping the fastening cap 50, the latter is deformed radially towards inside. A ring of this type is described in more detail in WO2007074274.

According to the invention, the metering chamber 25 contains at least one mobile element 100. In the example of FIG. 1, there are two mobile elements of spherical shape, such as balls, but any number of moving elements. , in particular three, and mobile elements of similar shapes, for example ovoid, are conceivable. The spherical (or ovoid) shape is advantageous, in particular to facilitate movement in the filled metering chamber, and to avoid any risk of attachment of product on said movable element. The presence of this at least one mobile element in the metering chamber substantially improves the performance of the valve, in particular by reducing the phenomenon of

Loss of dose. Advantageously, said at least one movable element is formed by a ball of high density capable of freely circulating in the metering chamber 25. The high density is desirable to allow the ball to be able to move efficiently in the active principle mixture (s) (s) - propellant (s) - excipient (s) present in the metering chamber. The dimensions of the ball or balls will of course be adapted as needed, and larger volume dosing chambers will allow the use of larger diameter balls. However, the objective being to allow the beads to peel off powder clumps adhered to the walls or joints, the use of a plurality of relatively small and dense beads will be preferred. The invention thus makes it possible to improve the uniformity of the active ingredient content of devices such as pressurized inhalers. (pMDI), this uniformity being one of the main problems with retention dosing chambers. The patient before taking his dose should shake the inhaler and the contents of the tank is well mixed because there is a gas phase and a liquid phase. In the dosing chamber, on the other hand, there is only liquid in a small volume, which limits the possibilities of movement. The addition of one or more balls circulating in the metering chamber during the agitation of the inhaler allows the formulation to be mixed more efficiently by creating shearing movements. Alternatively, the metering chamber could be formed of a plurality of axially extending metering channels, each containing one or more ball (s).

Other variants are also conceivable.

Loss of Dose (LOD) is determined by measuring the amount of active ingredient (s) not restituted when the dose of a metering valve is expelled after a period of storage. This effect, not advantageous, requires to multiply the number of actuations of the valve by the patient to reach the recommended dosage. Generally, dosages (eg for corticosteroids or bronchodilators) indicate taking the drug in two puffs. Most formulations consist of one or more HFA propellant (s) mixed with active principle (s) in the form of micronized powders, as well as optionally with one or more excipient (s) . A physical consequence is the sedimentation or creaming of the active principle (s) during storage periods. The effect of "Loss of Dose" is very strongly related to the problems of retention and adhesion of the active principle (s) in the metering chamber 25 of the valve. The invention, thanks to one or more moving elements, allows:

turbulent agitation of the fluids in the metering chamber to homogenize the dispersion of the active principle (s) in the formulation; - And / or mechanical shocks on the wall of the metering chamber to limit the bonding of the active principle (s) on the walls and joints. The table below indicates the percentages of active principle distributed during two successive actuations of the same valve, these two operations being spaced apart by a storage time (respectively 8h, 24h, 96h). These percentages are calculated on the basis of a ratio between the amount of active ingredient of the second puff compared to that of the first puff after said storage time. They therefore make it possible to determine the loss of dose. The higher the ratio, the lower the loss of dose. The formulation used comprises HFA 227 + Budesonide + excipients. The standard RCS valve is a standard ball-free metering valve, and the RCS ball valve is a metering valve with three balls. In both cases, the valve is shaken before being actuated. It is found that the presence of the beads makes it possible to substantially increase the level of active ingredient dispensed, and therefore to greatly reduce the effect of loss of dose.

It should be noted that the maximum efficiency is obtained by shaking the valve before its actuation, with the effect that the ball or balls will act on the one hand on the possible collages of active ingredients and on the other hand to homogenize the dose in the dosing chamber. Nevertheless, in particular for the devices used in the inverted position and stored in the upright position, simply turning the valve may be sufficient for the ball or balls to act in the dosing chamber.

Although the present invention has been described with reference to an alternative embodiment thereof shown in the drawings, it is understood that it is not limited to this variant, but that on the contrary a man of the can make any useful modifications. In particular, the structure of the valve can be any. Likewise, the shape of the valve body and the openings may be different from that shown. It is the same for the reservoir, and in particular of its neck, as well as the capsule or fixing ring which can be made differently, for example snap-on or screwable. In general, any modification is possible without departing from the scope of the present invention as defined by the appended claims.

Claims

claims

1.- Aerosol metering valve (20) for distributing fluid, comprising a valve body (21) containing a metering chamber (25) defined between a top seal (251) and a bottom seal (252), a valve ( 30) sealingly sliding against said up and down seals (251, 252) in said metering chamber (25), characterized in that said metering chamber (25) comprises at least one movable member (100) freely movable in said metering chamber (25), said at least one movable member being substantially spherical in shape, such as a ball.

2. Valve according to claim 1, wherein said at least one movable member is of high density relative to the density of the fluid contained in said metering chamber, and of small dimensions relative to the dimensions of said metering chamber.

3. Valve according to any one of the preceding claims, wherein said metering chamber comprises a plurality of movable elements, including two or three.

4. Valve according to any one of the preceding claims, wherein the reproducibility of the dose between two successive actuations, namely the amount of active ingredients distributed during the second actuation with respect to the amount of active ingredients distributed during the first actuation is greater than 80%, advantageously greater than 85%, preferably greater than or equal to 90%.

5. Valve according to any one of the preceding claims, wherein said metering chamber comprises axial channels each containing at least one spherical movable member.

6. Fluid dispensing device comprising a reservoir (1), characterized in that it comprises a valve (20) according to any one of the preceding claims.

7.- Device according to claim 6, wherein said valve (20) is assembled on said reservoir (1) by means of a fastener (50), such as a crimping capsule.

8.- Device according to claim 6 or 7, wherein a ring

(10) is assembled around said valve body (21), said ring (10) having a rigid inner portion (11) cooperating with the valve body (21) and a radially deformable outer portion (15).

9.- Device according to any one of the preceding claims, wherein said fluid product comprises active principle (s) in the form of micronized powder mixed with propellant, in particular of the type HFA-134a and / or HFA-227, in the possible presence of one or more excipient (s).